RecruitingPhase 3NCT05651841

REVErsing Airway Remodelling With Tezepelumab

REVErsing Airway Remodelling With Tezepelumab : a Protocol for a Double-blind Randomized Controlled Trial for Patients With Asthma

Sponsor

University Hospital, Montpellier

Enrollment

90 participants

Start Date

Mar 27, 2023

Study Type

INTERVENTIONAL

Conditions

Airway Remodelling, Asthmatic

Summary

The aim of this protocol is to perform a first randomized controlled trial evaluating how Tezepelumab affects the bronchial morphology (and computed tomographic variables in general) of asthmatic patients. In parallel, the investigators also hope to reproduce clinical benefits and perform a transcriptomic study that will juxtapose changes in genetic expression with changes in bronchial morphology and inflammatory signatures. The general hypothesis is that tezepelumab treatment is capable of at least partially reversing bronchial remodelling as detected on computed-tomographic (CT) scans. The investigators also expect such reversal to occur within a unique physiological repair environment that will be reflected by transcriptomic profiles

Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether tezepelumab — a biologic medication that blocks a trigger of airway inflammation — can reverse airway remodeling (permanent structural changes) caused by severe asthma. It uses CT scans to measure changes in the airways over time. **You may be eligible if...** - You are between 18 and 85 years old with a doctor-confirmed asthma diagnosis - Your asthma is poorly controlled despite treatment, with at least 1 severe or 2 moderate flare-ups in the past year - You are able to undergo CT scans **You may NOT be eligible if...** - You have another significant lung disease (like COPD) - You have had a severe asthma attack requiring hospital admission in the past 4 weeks - You are currently pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTezepelumab

Tezepelumab is supplied as a sterile, single-use, preservation-free, clear, colourless to slightly yellow liquid for subcutaneous administration in accessorized pre-filled syringes (APFS). Injections will be performed by study staff (doctors or nurses) during face-to-face study visits in participating centres. Subcutaneous injections are performed in a different body-part following the suggested rotation diagram.

OTHERplacebo

APFS containing analogous placebo identical in appearance: Injections will be performed by study staff (doctors or nurses) during face-to-face study visits in participating centres. Subcutaneous injections are performed in a different body-part following the suggested rotation diagram.

Locations(12)

CHU Dijon

Dijon, France

CHU Grenoble Alpes La Tronche

Grenoble, France

APHP Bicêtre

Le Kremlin-Bicêtre, France

CHRU Lille

Lille, France

Hôpital de la Croix Rousse

Lyon, France

Hôpital Nord Marseille

Marseille, France

CHU de Montpelier

Montpellier, France

APHP Bichat

Paris, France

Hôpital Foch

Paris, France

Hôpital Haut-Lévêque

Pessac, France

CHRU Strasbourg

Strasbourg, France

CHU Toulouse

Toulouse, France

View Full Details on ClinicalTrials.gov

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NCT05651841